Department of Health and Human Services September 2023 – Federal Register Recent Federal Regulation Documents

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.''

The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a priority review voucher for fiscal year (FY) 2024. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, authorizes FDA to determine and collect priority review user fees for certain applications for review of human drug or biological products when those applications use a tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) priority review voucher. These vouchers are awarded to the sponsors of tropical disease, rare pediatric disease, or material threat MCM product applications, respectively, that meet the requirements of the FD&C Act, upon FDA approval of such applications. The amount of the fee for using a priority review voucher is determined each fiscal year, based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the FY 2024 priority review fee rate applicable to submission of eligible applications for review of human drug or biological products using a rare pediatric disease, material threat MCM, or tropical disease priority review voucher and outlines the payment procedures for such fees.

For fiscal year 2023, HRSA will provide additional supplemental funds for the Emergency Medical Services for Children Innovation and Improvement Center to continue to provide assistance to a Pediatric Mental Health Care Access (PMHCA) award recipient so that they can improve access to PMHCA program activities in emergency departments.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

The Food and Drug Administration (FDA or we) is announcing the availability of two guidance documents that will help sprout operations subject to FDA's final rule entitled ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' (the Produce Safety Rule) understand the topics covered in the Produce Safety Rule pertaining to personnel qualifications, training, and hygienic practices; equipment, tools, and buildings; and sampling and testing of spent sprout irrigation water (or in-process sprouts). FDA is issuing a draft guidance entitled, ``Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption,'' which revises a currently issued draft guidance entitled ``Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations'' (January 23, 2017) (the January 2017 draft guidance). In addition, FDA is announcing the availability of a final guidance entitled ``Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption,'' which finalizes portions of the January 2017 draft guidance with additional clarifications in response to comments.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology.'' Physiologic closed-loop control (PCLC) devices are intended for automatic control of a physiologic variable(s) through delivery of energy or substance using feedback from physiologic sensors. PCLC devices may play an important role in reducing cognitive overload, minimizing human error, and enhancing medical care during emergency response and medical surge situations. This guidance provides technical considerations for PCLC technology in order to promote development and availability of safe and effective PCLC medical devices.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Electronic Submission Template for Medical Device De Novo Requests.'' FDA is issuing this draft guidance to introduce submitters of De Novo requests to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) to the current resources and associated content developed and made publicly available to support De Novo electronic submissions to FDA. This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guidance submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. This draft guidance is not final nor is it for implementation at this time.

On April 27, 2020, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), published a notice in the Federal Register announcing an extension of the deadline for annual reporting of data submitted for cigarettes and smokeless tobacco products, respectively, under the Federal Cigarette Labeling and Advertising Act (FCLAA) and the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA). CDC announced this extension due to the public health response to the COVID-19 pandemic. CDC has since re-evaluated this extension and determined that data submissions can recommence. Required ingredient reports and nicotine analysis reports must be submitted to CDC on or before March 31, 2024.

In fiscal year (FY) 2023, HRSA will provide supplemental funds to continue to provide technical assistance to pediatric primary care providers nationwide to connect them with Pediatric Mental Health Care Access (PMHCA) programs in their areas and to increase their capacity to provide pediatric mental and behavioral health care services.